Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
ConditionDiabetes Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas Woman's University
About this trial
Novel approaches to promote adherence to diabetic footwear and prevent high incidence of diabetes foot ulcers are urgently needed. Investigators propose to translate an innovative and practical technology to supplement clinical and risk evaluation for patients with diabetes through wearable insoles and smart watch, along with foot self-care education, to improve adherence to prescribed footwear and reduce incidence of foot ulcers in those with diabetes and at risk for foot ulcers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men or women 18 years old or older,
Diagnosis of Diabetes Mellitus,
Ambulatory, Uses prescribed diabetes footwear.
Those willing and able to attend follow up visits such as long distance (i.e. greater than 30 miles to recruitment sites).
Disqualifiers
Active Charcot Arthropathy or major foot deformity,
Cardiopulmonary disease (e.g. recent MI, Stroke),
Gangrene, active infection. Montreal Cognitive Assessment (MOCA<20).
Wide spread malignancy or systemically immunocompromising disease.
Trial design
Design model
Parallel
Treatments tested in this trial
A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion
BehavioralA 90-minute group session to educate patients on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch). Follow-up Care: A biweekly 30-minute one-on-one follow-up phone discussion (i.e., daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch, addressing feedback and questions regarding the intervention and prevention of foot-related complications).
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Smart insoles + EducationExperimental treatment 1 intervention
Group B: Smart InsolesNo intervention 0 interventions
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
A Change in Adherence to prescribed footwear is being assessed
Daily adherence will be track by Sensor Data and Self-Report Questionnaire. The real-time alert component of the smart insoles will be measured by the tagging of patients' diabetes shoes by Orthimeter (Germany). The system has 1-year battery life and enables continuous measuring adherence to footwear by measuring temperature. Participants will be required to record number of days adhered to footwear or alerts.
Time frame
2 months, 4 months and 6 monthsSecondary outcomes
1
A change in Response Rate to Alert and Unreported Alert Duration is being assessed
Successful response rate to alert and unreported alert will be assessed. Participants will report either low or high adherence to alert and duration. Investigators will report number of low and high alerts periods and activities.
Time frame
2 months, 4 months and 6 months2
A change in Foot Self-Care knowledge is being assessed
Improved in foot self-care knowledge and will be assessed with Foot Self-Care Knowledge and Practice which has 15 questions on knowledge and 15 questions for practice. Cronbach's alpha for the knowledge scale is 0.79, and practice is 0.72.
Time frame
Baseline and 6 months3
A change in Perception of Benefits is being assessed
User perception of benefits (Tech, Acceptance, Model). Participants will provide information on how strongly they agree or disagree with statements regarding benefits, acceptability, and ease of the wearable device on a 5-point scale: 1) strongly disagree; 2) somewhat disagree; 3) neutral; 4) somewhat agree; and 5) strongly agree. An average of 4 or higher indicates successful achievement on the TAM.
Time frame
2 months, 4 months and 6 months.Other outcomes
1
A change in Adherence to device wear is being assessed
Daily adherence to device wear will be recorded in hours (Sensor data and Self Report)
Time frame
2 months, 4 months and 6 months2
A change in Foot Ulcers is being assessed
The rate and incidence of foot ulcers will be measured baseline and 6 months. Participants will be assessed at baseline and 6 months for presence of foot ulcers. Participants will be ask to report at anytime any presence of ulcers during study.
Time frame
Baseline and 6 months3
A change in Off loading is being assessed
Participants' rate and number of times engage in offloading will be monitored. Participants will keep record and report offloading as well as collect data from the offloading device.
Time frame
2 months, 4 months, and 6 months4
A change in Acceptability and Ease of Use is being assessed
Acceptability and ease of use (Tech, Acceptance, Model). Participants will provide information on how strongly they agree or disagree with statements regarding benefits, acceptability, and ease of the wearable device on a 5-point scale: 1) strongly disagree; 2) somewhat disagree; 3) neutral; 4) somewhat agree; and 5) strongly agree. An average of 4 or higher indicates successful achievement on the TAM.
Time frame
2 months, 4 months and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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